Prostate Cancer Clinical Trial
Official title:
STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY
The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of
enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate
cancer who have serologic and/or radiographic disease progression despite primary androgen
deprivation therapy.
Throughout the study, safety and tolerability will be assessed by the recording of adverse
events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.
Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time
of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to
unblinding will be offered the opportunity to receive open label enzalutamide treatment.
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